This invention relates to a bag assembly for use in pharmaceutical manufacturing and for holding health care related solutions and, more particularly, to an improved bag assembly manufactured of silicone.
At the present time, virtually all bags used by the pharmaceutical industry and for holding health care related solutions (such as intravenous bags) are manufactured of polyvinyl chloride (PVC). PVC is a commonly used inexpensive plastic material which is naturally hard. To soften such material so that it can be used as a flexible bag and as flexible tubing, plasticizers such as phthalate esters are added to the PVC to soften it. Recently there has been concern that phthalates may leach from the PVC to which they have been added, thereby contaminating aqueous fluids held in PVC bags and traveling through PVC tubing. Since PVC bags are used to store intravenous solutions and blood for transfusions, phthalates which leach from the PVC are infused directly into a patient's bloodstream. It would therefore be desirable to have a phthalate-free bag and tubing for such purposes.